Deeply ingrained in our culture at CCS, is our commitment to clinical research. We are part of the Pediatric Clinical Trials Networkand our collaboration with NHRMCis always pushing us to uncover better ways to administer treatment and nutrition or prevent diseases. Our number one priority is the safety of our medically fragile patients and our number one goal is to improve and elevate the lives of neonates and children through state-of-the-art research.

We curently have 5 prospective studies and several retrospective studies including 2 drug studies, 2 equipment studies, one breast milk study and one focusing on children and diabetes. By bringing together a variety of perspectives and backgrounds, Coastal Children’s Services has developed an exceptional research program. Our team is constantly reviewing protocol and pushing forward to advance knowledge and solve the problems that impact the health of children in southeastern North Carolina.

Pediatric Research
Contributing to the development of treatments, drugs and devices specific to children is an important part of the Coastal Children’s Services mission. Children have often had to accept treatments and medications based on what is known to work in adults despite the fact that their metabolic pathways and organic functions differ widely. Even results from pediatric trials cannot be extrapolated to neonates. Neonates acquire conditions that occur exclusively in newborns, such as meconium aspiration syndrome and necrotizing enterocolitis. With that and the fact that off-label use is more rampant in newborns than in older children, pediatric and neonatal research are both priorities.

In addition to being a member of the Pediatric Clinical Trials Network, an alliance of clinical research sites cooperating in the design and conduct of pediatric clinical trials, Coastal Children’s Services also engages in pediatric research with independent sponsors and physicians to benefit the pediatric community at large.

Vision
To be a pioneer in the advancement of pediatric medicine through clinical research

Mission
To improve the lives of children by advancing evidence-based knowledge in pediatric care_______________________________________________________________________

DescriptionOwn mother’s colostrum (OMC) and milk (OMM) help protect extremely premature infants (those born less than 1250 grams) against neonatal morbidity and mortality. This study will evaluate the safety, efficacy and health outcomes of administering OMC/OMM directly inside the mouth of infants into the cheek cells. Multiple centers are participating in this 5 year study and ultimately 622 patients will be enrolled from across all of the sites. Our goal is to enroll 100 subjects from our NICU. As of July 2018, we have enrolled 46 subjects.

. Funding Source: Northshore University Health System Research Institute

DescriptionInfants who are born between 23 - 30 weeks gestational age have a high risk of developing respiratory distress syndrome and often require mechanical breathing assistance from a ventilator. The purpose of this study is to evaluate the use of a specific ventilator, the Infinity Acute Care System Workstation Neonatal Care Babylog VN400 in the High Frequency Oscillatory Ventilation (HFOV) mode (Babylog VN500 in HFOV mode, for short) to determine if it provides a more gentle ventilation system to very low birth weight infants. The Babylog VN400 in HFOV mode has been available outside of the United States for the past few years. However, the HFOV mode has not been approved by the Food and Drug Administration (FDA) and is considered experimental in the US. The purpose of this study is to test the HFOV mode on the ventilator and compare results to retrospective data from similar babies treated with other FDA-approved HFOV devices during the last two years. The study results will be used to gain FDA approval for this investigational device. The study is enrolling infants at many different locations and ultimately 225 infants will be enrolled. Our goal is to enroll 20 babies from our NICU. As of April 2016, we have enrolled 2 subjects.Funding Source: Draeger Medical Systems
Closed to enrollment but has continued long term follow up

FUROSEMIDE STUDY (Initiated May 2016)

TitleSafety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD

DescriptionInfants who are born at less than 29 weeks gestational age are at greatly increased risk for developing a lung disease known as Bronchopulmonary Dysplasia or BPD. BPD is the most common lung disease in preterm infants and is associated with life-long problems. The purpose of this study to learn about the safety, potential side effects and dosing of a medicine called Furosemide (aka Lasix) when it is given to infants who are at risk for developing BPD. The results of this study will help us find the safest and most helpful doses of furosemide to give to preterm infant to treat or prevent BPD. The study is enrolling infants at many different locations and ultimately 120 infants will be enrolled. Our goal is to enroll 12 infants from our NICU. As of July 2018, we have enrolled 6 subjects. Funding Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Outpatient Clinic Studies

Title: Merck

Description: A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin) in Pediatrics Patients with Type 2 Diabetes Mellitus with inadequate glycemic control on metformin therapy (alone or in combination with insulin) For treatment of pediatric patients 10-17 years of age. As of July 2018, we have enrolled 2 patients with the expectancy enrollment total of 3.

Title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Description: A prospective, multi-center, open label, PK and safety study. The primary objective is to determine the pharmacokinetics (PK) of selected antiepileptics in obese children and adolescents. The second objective is to evaluate the safety of selected anti-epileptics in obese children and adolescents. For treatment of pediatric patients 2-18 years of age (Enrollment Starting Soon)

Research Staff

Donna Vaught, PhD Director of Research Donna Vaught completed both her undergraduate and graduate school training at Virginia Polytechnic Institute & State University. She received her Ph.D. in Developmental Psychology in 1990 and completed a postdoctoral fellowship at the Kennedy Krieger Institute in 1991. Donna is NIDCAP trained and has been working with the NICU at NHRMC since September 1996. In addition to her duties at the hospital, Donna is a part-time instructor in the Department of Psychology at University of North Carolina - Wilmington.

Tiffony Blanks Research Project ManagerTiffony completed her undergraduate degree at the University of Mount Olive. She received her Bachelor of Science degree in Business Administration and Health Care Management. Tiffony recently joined Coastal Carolina Neonatology's research team after 16 years with NHRMC, where she worked last in the NICU as a Patient Care Technician and ROP Coordinator. She is eager to learn more regarding research with neonates and excited to be a part of such a great team.

presented at
Pediatric Academic Societies, Vancouver, BC
The Pediatric Academic Societies (PAS) Annual Meeting is the largest international meeting focused on research in child health. We bring together a variety of groups to—not only discuss original research, which has been the hallmark of the PAS meet- ing, but to also discuss how this research can be applied to actual clinical practice in pediatrics. This alliance also provides opportunity to discuss other critical issues that affect child health such as public policy and advocacy. click for photos
2013 STUDIESA Prospective Randomized Controlled trial Comparing the Accuracy of
a Weight-Based Method to the NRP Method for NGt/OGt insertion depth in Neonates.
Presented by Fernando Moya, MDPoster pdfOriginal abstract doc

presented at
Pediatric Academic Societies, Washington DC
The Pediatric Academic Societies (PAS) Annual Meeting is the largest international meeting focused on research in child health. We bring together a variety of groups to—not only discuss original research, which has been the hallmark of the PAS meet- ing, but to also discuss how this research can be applied to actual clinical practice in pediatrics. This alliance also provides opportunity to discuss other critical issues that affect child health such as public policy and advocacy. click for photos